1. Technical Field
This invention relates to packages for surgical sutures, and more particularly to folded, molded or vacuum-drawn plastic dispensers for certain kinds of sutures having needles attached hereto.
2. Background Art
Packages for surgical sutures having needles attached at one or both ends are constructed according to the nature of the suture material and to how the sutures will be used. Generally, the package holds the suture and attached needles in place, protects them during handling and storage, and allows ready access to the suture for removal with minimum handling at the time the suture is to be used. The suture should also be removable without becoming entangled with itself, kinked or coiled in undesired ways. The nature of the suture material itself may impose limitations on the configuration of the package, how the suture is placed within the package, the placement of the needles, or how the suture is drawn from the package.
A frequently used form of package consists of a folded stiff treated paper suture holder contained in a sterile, hermetically sealed envelope, which envelope is further sealed in a second, usually clear, thermoplastic heat-sealed envelope outer wrap to maintain the suture holder and inner envelope sterile. When the suture is to be used, the outer clear wrap is opened in the operating room and the sealed sterile inner envelope deposited in a sterile area. Sterile personnel then open the inner envelope when access to the suture is needed. A number of these direct dispensing packages represent great advances in the art of surgical suture packaging, but many of them do not address the problems associated with the peculiar properties of sutures manufactured from porous expanded polytetrafluoroethylene (PTFE), which has been prepared in accordance with one or more U.S. Pat. Nos. 4,187,390; 4,110,392; 4,096,227; 3,962,153 and 3,653,566. Many of the prior packages are not suitable in that crimping, flattening, tangling, or knotting may occur during loading, handling, or removing a PTFE suture from the package. Cuts and slots or other breaks in the surface smoothness in the suture holding area of the paper holder associated with loading or holding a suture-tend to damage a PTFE suture drawn across the cut edge. It has been found that mechanically loading a PTFE suture in a package by winding the suture about mandrels or reels in a figure eight or a circular configuration tends to induce tangling or knotting of the suture upon removing it from the package. Any loading pattern in which the PTFE suture intersects itself can lead to knotting. Friction pads, such as those made from polymer foam, used to hold a suture in place, also tend to induce tangling and knotting. Cotton and silk sutures have also been found to sometimes tangle or knot under the same circumstances as PTFE sutures and hence the suture holder of this invention can be usefully employed for sutures manufactured from cotton or silk, or other pliable suitable material. Additionally, although many suture packages attempt to fix any attached needles in a particular location for easy presentation to the user, it has been found that often the needles become dislodged and are not conveniently presented to the user. If the needles do remain fixed in place, they are often accessible from one direction only.
Reel windup suture holders molded from plastic, such as those disclosed by U.S. Pat. Nos. 3,545,608, 3,648,949, and 4,084,692, have advantages for many sutures. PTFE sutures will, however, generally quickly tangle or knot when withdrawn from these or similar types of reels. Coiled narrow passageways molded in plastic are shown by U.S. Pat. Nos. 3,338,401 and 3,972,418, wherein several sutures lie side by side along the passageway. These also are not suitable in that PTFE sutures may generally not be drawn past one another along their length without entanglement and knotting.
Thus, the plastic suture dispensing pack of this invention has several advantages over prior art packages for PTFE sutures. The advantage of non-overlapping or PTFE suture strands is combined with holding of the needles in a fixed position in a unique orientation which presents the needles in such a way that they may be gripped from either side of the package by a needle holder. Right-handed or left-handed removal of the needle and suture is equally facile. The needles are immediately visible in a slot in the top of the suture folder on only a partial peeling back of the inner protective envelope and can be immediately gripped in the slit from either side of the pack and the suture easily withdrawn from the pack without further opening of the protective envelope.